TriangleNCT04303780 · OUTCOME
Progression-free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline up to primary analysis data cut-off date (02 August 2022); max time on study as of primary analysis data cut off was 24.3 months
What was measured
PFS was defined as the time from randomization (baseline) until disease progression or death from any cause, whichever occurred first for all participants. Progression was based on blinded independent central review (BICR) of disease response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). As pre-specified in the statistical analysis plan, for participants who crossed over from docetaxel to AMG 510, the participant's response post first progression or post crossover was not used for the primary analyses. Data are presented per original treatment randomized.
Analysis population: Measured in the Full Analysis Set (FAS), which included all randomized participants.
Groups in this outcome
AMG 510
Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 960 mg of AMG 510 orally via tablets QD in each 21 day cycle.
Docetaxel
Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 75 mg/m\^2 of docetaxel via intravenous (IV) infusion once every 3 weeks (Q3W) in each 21 day cycle. Participants who were determined to have radiological progression according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by the investigator and progressive disease confirmed by independent central imaging review, could have switched to receive AMG 510. Alternatively, if an early efficacy of the study is noted by the data monitoring committee, crossover would be considered for all participants who randomized into the docetaxel arm (so that they are able to immediately receive AMG 510).
| Group | Source count |
|---|---|
| AMG 510 | 171 |
| Docetaxel | 174 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AMG 510 | 5.62 | Not reported | 4.27 | 7.75 | Not reported |
| Docetaxel | 4.47 | Not reported | 3.02 | 5.68 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.509
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.864
- group Ids
- OG000
- OG001
- non Inferiority Comment
- A hazard ratio \<1.0 indicates a lower average event rate and a longer PFS for AMG 510 relative to docetaxel. P-value was calculated using a stratified log-rank test.
- non Inferiority Type
- EQUIVALENCE
- p Value
- 0.002
- param Type
- Hazard Ratio (HR)
- param Value
- 0.663
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.509
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.864
- group Ids
- OG000
- OG001
- non Inferiority Comment
- A hazard ratio \<1.0 indicates a lower average event rate and a longer PFS for AMG 510 relative to docetaxel. P-value was calculated using a stratified log-rank test.
- non Inferiority Type
- EQUIVALENCE
- p Value
- 0.002
- param Type
- Hazard Ratio (HR)
- param Value
- 0.663
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.27
- upper Limit
- 7.75
- value
- 5.62
- group Id
- OG001
- lower Limit
- 3.02
- upper Limit
- 5.68
- value
- 4.47
- denoms
- counts
- group Id
- OG000
- value
- 171
- group Id
- OG001
- value
- 174
- units
- Participants
- description
- PFS was defined as the time from randomization (baseline) until disease progression or death from any cause, whichever occurred first for all participants. Progression was based on blinded independent central review (BICR) of disease response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). As pre-specified in the statistical analysis plan, for participants who crossed over from docetaxel to AMG 510, the participant's response post first progression or post crossover was not used for the primary analyses. Data are presented per original treatment randomized.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 960 mg of AMG 510 orally via tablets QD in each 21 day cycle.
- id
- OG000
- title
- AMG 510
- description
- Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 75 mg/m\^2 of docetaxel via intravenous (IV) infusion once every 3 weeks (Q3W) in each 21 day cycle. Participants who were determined to have radiological progression according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by the investigator and progressive disease confirmed by independent central imaging review, could have switched to receive AMG 510. Alternatively, if an early efficacy of the study is noted by the data monitoring committee, crossover would be considered for all participants who randomized into the docetaxel arm (so that they are able to immediately receive AMG 510).
- id
- OG001
- title
- Docetaxel
- param Type
- MEDIAN
- population Description
- Measured in the Full Analysis Set (FAS), which included all randomized participants.
- reporting Status
- POSTED
- time Frame
- Baseline up to primary analysis data cut-off date (02 August 2022); max time on study as of primary analysis data cut off was 24.3 months
- title
- Progression-free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice